Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The allergenic potential of the test item (intermediate) was not determined. There are reliable studies of an analogue substance (final product) available to assess the skin sensitizing potential. The compounds share high similaritiy in structure, are of low water solubility and have a log Pow > 8. The toxicity profile of the analogue as well as of the test item is determined by the main component; the side products are structural analogues of the main product without influence on substance toxicity. The test item as well as the analogue are poorly soluble and have a molecular weight of 494 g/mol and 606 g/mol, respectively, which indicates low skin permeability and low bioavailability. It is, therefore acceptable to derive information on acute toxicity from experimental data of the read across substance.

A detailed risk assessment and read across justification was send to the german chemical agency BAuA in 2007 with the purpose of a national substance notification (VIIA). The read across justification was accepted by the national agency.

In a GLP conform study the cutaneous allergenic potential of the analogue (purity: > 98 weight- %), was assessed using the Maximization-Test (GPMT) in accordance with OECD Guideline No. 406 (RCC Ltd, 2002). The test was performed in 15 (10 test and 5 control) male albino guinea pigs. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 10% dilution of the test item in PEG 300 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 25 % in PEG 300 one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 1 % in PEG 300 and PEG 300 alone under occlusive dressing.

Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. The sensitising potential of the test substance was classified according to the grading of Magnusson and Kligman.

No toxic symptoms were evident in the guinea pigs of the control or test group. None of the control and test animals showed skin reactions after the challenge treatment with the test item at 1 % (w/w) in PEG 300.


Migrated from Short description of key information:
The potential for skin sensitization of the test substance was not assessed. Information on sensitization are derived from a strucutral analogue. A Guinea Pig Maximisation Test (GPMT) was performed to examine the sensitizing potential of the substance. As a result, the test material is not a skin-sensitizer (GLP, OECD 406; RCC Ltd, 2002)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).